FDA Inspection
Advanced Magnetic Research Institute Institutional Review BoAdvanced Magnetic Research Institute Institutional Review Bo – FDA Inspection, Oct 25, 2016
Record Details
This FDA Inspection record concerns Advanced Magnetic Research Institute Institutional Review Bo, with an inspection on October 25, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 25, 2016
- Product Type
- Devices
View Company Profile
ID · c122e46f-6fad-487b-8fec-c2b32de3f3a8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 993321
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 50.25(a)(3)Benefits to the subject
- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.106(a)IRB for CI"s in support of research/marketing permits
- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 50.51Provisions for soliciting assent and permission
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
- 21 CFR 56.106(a)IRB for CI's in support of research/marketing permits
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.